BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 4093658 · Received September 16, 2014

    Report

    Report Number
    1525712-2014-05906
    Event Type
    Malfunction
    Date Received
    September 16, 2014
    Report Date
    August 26, 2014
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    DEALER CALLS TO REPORT ENDUSER STATES SHE WAS ALMOST HIT BY TRAIN IN CHAIR, STATES SOMEHOW THE CHAIR FLIPPED OVER RIGHT BY THE TRACKS, STATES SHE WAS SO CLOSE HER LEGS WERE TOUCHING THE TRAIN, SOMEHOW SHE MANAGED TO FLIP THE CHAIR BACK OVER, AND WAS NOT INJURED PER THE DEALER. DEALER STATES THEY ARE NOT SURE WHAT THE STORY IS ON THIS ISSUE, STATES THERE WAS AN INCIDENT, WITH A CHAIR AND A TRAIN THEY DID WITNESS, JUST UNSURE OF HOW EVERYTHING ACTUALLY HAPPENED. DEALER IS REPORTING L MOTOR DAMAGE, LEFT MOTOR MOUNT DAMAGE, AND BENT BATTERY BOX, ALSO COSMETIC DAMAGE ALL OVER THE CHAIR

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573339 POWERED WHEELCHAIR 890.3860 ITI INVACARE TAYLOR STREET TDXSI-HD

    Patients

    Seq Age Sex Outcome Treatment
    1 Other